Early Development of Sleep-wake Cycles in Premature Infants and Its Impact on Neurodevelopmental Outcome (SWC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Medical University of Vienna
Sponsor:
Collaborator:
Austrian Science Fund (FWF)
Information provided by (Responsible Party):
Katrin Klebermass-Schrehof, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01774318
First received: January 4, 2013
Last updated: January 20, 2013
Last verified: January 2013
  Purpose

Due to the development of neonatal intensive care the number of surviving premature infants increased significantly. The immature brain undergoes a fair amount of external stimuli, which have a great impact on later cognitive development. Increasingly data show, that a delayed emergence of sleep-wake-cycling in newborns can be the first sign of brain injury. Studies have shown that clearly defined sleep states can be identified from 31-32 weeks of gestation onwards. But a few studies show, that also extremely premature infants already show cyclical variations of the background pattern within amplitude-integrated EEG (aEEG= a time-compressed, simplified EEG) and conventional EEG. This might resemble early sleep-wake-states and their presence correlates to the integrity of the central nervous system, although no clearly defined "sleep states" according to the classical definition can be identified. Complex EEG analysis needs the use of automated methods to exclude personal bias and to ensure gestational age specific data analysis. The newly developed NLEO algorithm was specially designed for EEG analysis of premature infants. Conventional EEG within this study will be analyzed visually and with the automated algorithm. In our research project we will study the emergence of Sleep-wake-cycling in extremely premature infants and its impact on their neurodevelopmental outcome prospectively. The different sleep and wake states will be derived from analysis of the conventional Video-EEG, aEEG and polysomnographic measurements. Visual analysis will include assessment of amplitudes and frequencies as well as the latencies and durations of EEG-Bursts and Interburst intervals. The automated NLEO-algorithm will be firstly used for comparison with above described visual analysis and secondly to find regions of interest involved in the organization of these early sleep states. The aim of this study is first to understand and analyze in detail the emergence of sleep-wake cycling including its disturbances in premature infants and to compare automated NLEO algorithm to conventional visual analysis methods. Secondly to correlate neurodevelopmental outcome to the emergence of sleep-wake-cycling.


Condition Intervention
Sleep Disorders, Circadian Rhythm
Other: aEEG and conventional EEG measurement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Early Development of Sleep-wake Cycles in Premature Infants and Its Impact on Neurodevelopmental Outcome

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • description of Sleep-wake-cycles in aEEG and conventional EEG [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    parallel assessment of sleep-wake cycles in aEEG and conventional EEG


Secondary Outcome Measures:
  • Correlation of occurrance of sleep-wake-cycles to neurodevelopmental outcome [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    correlation of sleep-wake-cycles to Bayley Scales of Infant Development assessed at the age of 2 years


Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
preterm cohort
preterm infants born at medical university of vienna and born at gestational age 23+0 - 28+6 weeks of gestation intervention: aEEG and conventional EEG measurements will be performed every two weeks untill 36 weeks of gestation
Other: aEEG and conventional EEG measurement
aEEG and conventional EEG measurement including video-polysomnography

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   23 Weeks to 29 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: preterm infant born below 29+0 weeks

Exclusion Criteria:

severe cerebral malformation

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774318

Locations
Austria
Medical University Vienna Recruiting
Vienna, Austria, 1090
Contact: Katrin Klebermass-Schrehof, MD    0043/1/40400/2930    katrin.klebermass-schrehof@meduniwien.ac.at   
Principal Investigator: Katrin Klebermass-Schrehof, MD         
Sponsors and Collaborators
Medical University of Vienna
Austrian Science Fund (FWF)
Investigators
Principal Investigator: Katrin Klebermass-Schrehof, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Katrin Klebermass-Schrehof, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01774318     History of Changes
Other Study ID Numbers: KKS-01-2012
Study First Received: January 4, 2013
Last Updated: January 20, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
sleep-wake-cycles
preterm infants
aEEG
conventional EEG
polysomnography

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases

ClinicalTrials.gov processed this record on August 21, 2014